两种HIV-1新发感染检测试剂性能的评估

Performance assessment of two kinds of HIV-1 recent infection detection reagent

目的对国内常用的两种1型艾滋病病毒(HIV-1)新发感染酶免检测试剂盒(限制性抗原亲和力法)进行精密度和稳定性评估,比较两种试剂的性能。方法利用2份临床样本和试剂盒内的校准品分别测定两种试剂盒的批内精密度;利用81份HIV-1抗体阳性样本评估两种试剂盒初筛、确证和不同人员检测结果的重现性;用37℃处理比较两种试剂盒的储存稳定性。结果批内精密度检测显示,校准品、新发和既往感染样本用A试剂盒检测的光密度(OD)变异系数(CV)为7.87%、6.93%和8.58%,B试剂检测的CV值为6.69%、10.75%和7.84%。A、B两种试剂盒经同一实验员检测的初筛和确证标准化光密度(ODn)值相关性分别为0.9501和0.9803;不同实验员间检测A、B两试剂盒的ODn值相关性分别为0.9634和0.9912。两种试剂盒37℃处理7天和正常存放的试剂盒检测81份样本的结果符合率达97.53%。结论两种试剂盒具有较好的精密度、检测结果稳定、易于储存,能够满足实验室HIV-1新发感染检测,可以在国内艾滋病新发感染检测实验室推广和应用。

Objective To evaluate the performance of the two kinds of limiting antigen avidity (LAg)EIA reagent,and compare the applicability of these two kinds of reagent in detecting HIV-1incidence.Methods We evalu- ated the coefficient variation (CV)within group precision of the two kinds of reagent;obtained the coincidence rate of screening and confirmation ODn values in the same reagent detected by the same experimenter,and obtained the coincidence rate of screening ODn values in 81 samples detected by different experimenters.We also analyzed the heat-stability of the two kinds of reagent by treating the reagent in 37℃ for one week.Results The OD value CV within group precision for A regent was 7.87%,6.93% and 8.58%;and B regent was 6.69%,10.75% and 7.84%by testing one recent and long-time infection clinical sample,and the calibration in the kit.As for A and B regent,the coincidence rate of the initial screening and confirmation ODn values in one experimenter were 0.9501 and 0.9803 respectively;and the coincidence rate of ODn values tested by different experimenters were 0.9634 and 0.9912.The coincidence rate of the two kinds of reagent was 97.53%in 37℃ treated for one week and normal storage.Conclusion The two kinds of reagents have good precision,repeatability and stability,which can satisfy and apply for detection of HIV-1 incidence in AIDS testing laboratory.